<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20130701013828N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Protective effects of Bisoprolol against anthracycline-induced cardiomyopathy in breast cancer patient</public_title>
      <acronym></acronym>
      <scientific_title>Protective effects of Bisoprolol against anthracycline-induced cardiomyopathyin in breast cancer patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study use block randomization and unit of randomization is individual. Block randomization divides patients into M blocks of size 2N, so that in each block N patients are assigned A and patients N are assigned to B. The block is then selected randomly.The size of the block is not stated in the study so that researchers are blind to it.Rand Excel function randomization tool is helpful, Blinding description: Patients are treated with medication packages pre-determined by the study supervisor. Drug packages are exactly the same in shape and the patient and the project facilitator are not aware of the contents of the packages. The executor and his assistant are done who are not aware of the contents of the packages; In the data analysis stage, the analysis will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group 1 or 2) will be identified for data analysis; Therefore, the study is three-blind and the contents of the two drug groups are not clear from the stage of patient entry into the study to the study, data collection and analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>chemotherapy induced cardiomyopathy in breast cancer patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 2.5 mg Bisoprolol tablets from Abidi company are taken daily from one week before the start of chemotherapy until the end of the chemotherapy course. Intervention 2: Control group: Placebo is given to the control group like intervention group from one week before the start of chemotherapy until the end of the chemotherapy course.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ahmad Mirdamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Najafabad Branch,University Blvd,Najafabad,Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 31 4229 1111</telephone>
        <email>drsamirdamadi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Mirdamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan,shariati street,shariati hospital</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 31 1223 8028</telephone>
        <email>drsamirdamadi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with breast cancer
Patients with indication for AC (doxorubicin hydrochloride (Adriamycin) and cyclophosphamide) regimen for chemotherapy
Patients agreement</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients non compliance
Patients who have cardiovascular problems
Have  previously undergone chest radiotherapy
Patients who have allergy to Bisoprolol
Patients currently taking beta-blockers
Patients who have contraindicated for use beta blockers.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 2.5 mg Bisoprolol tablets from Abidi company are taken daily from one week before the start of chemotherapy until the end of the chemotherapy course</i_keyword>
      <i_keyword>Control group: Placebo is given to the control group like intervention group from one week before the start of chemotherapy until the end of the chemotherapy course</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LVEDV(left ventricular end diastolic volume). Timepoint: The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention. Method of measurement: Specialized echocardiography.</prim_outcome>
      <prim_outcome>(GLS)global longitudinal strain. Timepoint: The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention. Method of measurement: Specialized echocardiography.</prim_outcome>
      <prim_outcome>LVESD(left ventricular end systolic diameter). Timepoint: The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention. Method of measurement: Specialized echocardiography.</prim_outcome>
      <prim_outcome>LVEDD(left ventricular end diastolic diameter). Timepoint: The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention. Method of measurement: Specialized echocardiography.</prim_outcome>
      <prim_outcome>LVESV(left ventricular end systolic volume). Timepoint: The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention. Method of measurement: Specialized echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiotoxicity. Timepoint: before chemotherapy and end of chemotherapy. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Dizziness. Timepoint: after start of drug. Method of measurement: Ask patient.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-22</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>School of Medicine ,Isfahan University,Azad Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
